845 1401 10 02 03 February 2004/1 HITACHI 717 Chemistry settings Temperature: 37 °C PROGRAM 2: CHEMISTRY PARAMETERS TEST CHE ASSAY CODE 5 – 30 – 50 SAMPLE VOLUME (μl) 4 R 1 VOLUME (μl) 200 – 100 – NO R 2 VOLUME (μl) 50 – 20 – NO WAVELENGTH (nm) 0 – 405 CALIBR. METHOD **2 – 0 – 0 STD.1 CONC.-POS. 0 – 1 STD.2 CONC.-POS. 0 – 0 STD.3 CONC.-POS. 0 – 0 STD.4 CONC.-POS. 0 – 0 STD.5 CONC.-POS. 0 – 0 STD.6 CONC.-POS. 0 – 0 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 1 PROZONE LIMIT 0 EXPECTED VALUE 3930 – 11500 PANIC VALUE 0 - 25000 INSTRUMENT FACTOR 1.0 #) Data entry by the user *) Enter calibration or standard value and position **) Factor must be checked by a calibration serum CHOLINESTERASE FS Order information Cat. No. 1 1401 .. .. … Notes 1. Please refer to the package insert for Cholinesterase FS for detailed information about the test on the following: Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding - Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison Reference Ranges Literature 2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided. 3. Manufactured by DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
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#) Data entry by the user *) Enter calibration or standard value and position **) Factor must be checked by a calibration serum
CHOLINESTERASE FS Order information Cat. No. 1 1401 .. .. … Notes 1. Please refer to the package insert for Cholinesterase FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
845 2701 10 02 10 October 2009/3
ALAT(GPT) FS (IFCC mod.) Cat. No 1 2701.........
Notes 1. Please refer to the package insert for ALAT(GPT)
FS (IFCC Mod.) for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 0220 10 02 10 September 2006/3
ALBUMIN FS Cat. No 1 0220.........
Notes 1. Please refer to the package insert Albumin FS for
detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 0242 10 02 10 August 2008/3
ALBUMIN IN URINE CSF/FS (Microalbumin) Serum application
Cat. No 1 0242.........
Notes 1. Please refer to the package insert for Albumin in
Urine/CSF FS *Microalbumin for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer **) For Hitachi 902 calibrators, controls and samples
must be prediluted 1+20 before analysing
845 0242 10 52 10 August 2008/4
ALBUMIN IN URINE/CSF FS (Microalbumin) Urine/CSF application Cat. No 1 0242.........
Notes 1. Please refer to the package insert for Albumin in
Urine/CSF FS *Microalbumin for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 0401 10 02 10 October 2009/4
ALKALINE PHOSPHATASE FS DGKC Cat. No 1 0401.........
Notes 1. Please refer to the package insert for Alkaline
Phosphatase FS DGKC for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 0401 10 02 10 October 2009/4
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST AP # TEST NAME AP UNIT U/L
DATA MODE ON BOARD REPORT NAME Alk. Phos
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
0 - 258 0 - 258
TECHNICAL LIMIT CLASS I CLASS 2
0 - 800 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 4 0 0 # (1)
(2) * # 4 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST AP
ASSAY CODE Rate A 10 WAVELGTH (SUB / MAIN)
700 / 415
ASSAY POINTS 20 - 31 - 0- 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 4 0 0
S. VOL (DECREASE) 2 0 0
S.VOL (INCREASE) 8 0 0
ABS. LIMIT 11000 2:INCREASE
PROZONE LIMIT 0 1:HIGHER
REAGENT R1 200 0 084 #
R2 0 0 084 #
R3 50 0 084 #
R4 0 0 084 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 500
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ** The given factor must be checked by a calibratior ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name ALP 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 415 11 Sample Volume 4 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 13000 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 64 55 Expect. Value (H) 306 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 0441 10 02 10 October 2009/6
ALKALINE PHOSPHATASE FS IFCC 37 °C Cat. No 1 0441.........
Notes 1. Please refer to the package insert for Alkaline
Phosphatase FS IFCC for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is 8 days provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems
GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 0441 10 02 10 October 2009/6
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST AP # TEST NAME AP UNIT U/L
DATA MODE ON BOARD REPORT NAME Alk. Phos
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED
VALUE
CLASS 2
AGE M F
- -
- -
# - # # - #
TECHNICAL LIMIT CLASS I CLASS 2
0 - 1400 -
STD CO
N
PO
S
S.VO
L.
PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 4 0 0 # (1)
(2) * # 4 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST AP
ASSAY CODE Rate A 10 WAVELGTH (SUB / MAIN)
700 / 415
ASSAY POINTS 20 - 31- 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 4 0 0
S. VOL (DECREASE) 2 0 0
S.VOL (INCREASE) 8 0 0
ABS. LIMIT 13000] 2:INCREASE
PROZONE LIMIT 0 1:HIGHER
REAGENT R1 200 0 158 #
R2 0 0 158 #
R3 50 0 [158 #
R4 0 0 158 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 100
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ** The given factor must be checked by a calibratior ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name ALP 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 415 11 Sample Volume 4 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 13000 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 42 55 Expect. Value (H) 141 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 0501 10 02 10 October 2009/5
-AMYLASE CC FS Cat. No 1 0501.........
Notes 1. Please refer to the package insert for -Amylase
CC FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 7102 10 02 10 October 2009/6
APOLIPOPROTEIN A1 FS Cat. No. 1 7102.........
Notes 1. Please refer to the package insert for Apoliporotein
A1 FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 7112 10 02 10 May 2009/4
APOLIPOPROTEIN B FS Cat. No 1 7112.........
Notes 1. Please refer to the package insert for Apoliporotein
B FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 2601 10 02 10 March 2010/4
ASAT(GOT) FS (IFCC mod.) Cat. No 1 2601.........
Notes 1. Please refer to the package insert for ASAT(GOT)
FS (IFCC mod) for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 2601 10 02 10 March 2010/4
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST ASAT # TEST NAME ASAT UNIT U/L
DATA MODE ON BOARD REPORT NAME ASAT
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
# - # # - #
TECHNICAL LIMIT CLASS I CLASS 2
0 - 700 -
STD CON POS S.VOL
.
PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 15 0 0 # (1)
(2) * # 15 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST ASAT
ASSAY CODE Rate A 10 WAVELGTH (SUB / MAIN)
415 / 340
ASSAY POINTS 20 - 31- 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 15 0 0
S. VOL (DECREASE) 7 0 0
S.VOL (INCREASE) 25 0 0
ABS. LIMIT 6000] 1:DECREASE
PROZONE LIMIT 0 LOWER
REAGENT R1 200 0 105 #
R2 0 0 105 #
R3 50 0 105 #
R4 0 0 105 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 200
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ** The given factor must be checked by a calibratior ## Enter the next code ATTENTION This kit is for use with the original application. If you wish to use this included DiaSys application please contact your supplier for additional bar code labels.
#) Data entry by the user *) Calculated by the analyzer
845 7012 10 02 10 July 2009/5
ANTISTREPTOLYSIN O FS Cat. No 1 7012.........
Notes 1. Please refer to the package insert for Antistreptolysin
O FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at
least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 0950 10 02 10 August 2008/5
BICARBONATE FS Cat. No 1 0950.........
Notes 1. Please refer to the package insert for Bicarbonate
FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
3 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 0950 10 02 10 August 2008/5
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST CO2 # TEST NAME CO2 UNIT mmol/l
DATA MODE ON BOARD REPORT NAME CO2
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
22 - 29 22 - 29
TECHNICAL LIMIT CLASS I CLASS 2
0 - 50 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 3 0 0 # (1)
(2) * # 3 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST CO2
ASSAY CODE 2 Point end 10 WAVELGTH (SUB / MAIN)
505 / 415
ASSAY POINTS 2 - 25 - 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 3 0 0
S. VOL (DECREASE) 2 0 0
S.VOL (INCREASE) 6 0 0
ABS. LIMIT 0 DECREASE
PROZONE LIMIT 0 LOWER
REAGENT R1 300 0 156 #
R2 0 0 156 #
R3 0 0 156 #
R4 0 0 156 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 200
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name CO2 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 5 6 Assay Point 2 30 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 505 10 Wave Leng. (MAIN) 415 11 Sample Volume 3.0 12 R1 VOLUME 300 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 0 19 R3 Pos. 0 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 200 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Decrease 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 22 55 Expect. Value (H) 29 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 0821 10 02 10 October 2008/4
BILIRUBIN AUTO DIRECT FS Cat. No 1 0821.........
Notes 1. Please refer to the package insert for Bilirubin Auto
Direct FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 0821 10 02 10 October 2008/4
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST DBIL # TEST NAME DBIL UNIT mg/dl
DATA MODE ON BOARD REPORT NAME Bilirubin Direct
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
0 - 0.2 0 - 0.2
TECHNICAL LIMIT CLASS I CLASS 2
0 - 10.0 -
STD CON POS S.VOL
.
PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 10 0 0 # (1)
(2) * # 10 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST DBIL
ASSAY CODE 2 point end 10 WAVELGH (SUB / MAIN)
660 / 546
ASSAY POINTS 15 - 31- 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 10 0 0
S. VOL (DECREASE) 5 0 0
S.VOL (INCREASE) 20 0 0
ABS. LIMIT 0 2:INCREASE
PROZONE LIMIT 32000 1:HIGHER
REAGENT R1 240 0 294 #
R2 0 0 294 #
R3 60 0 294 #
R4 0 0 294 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 200
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name DBIL 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 546 11 Sample Volume 28 12 R1 VOLUME 280 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 32000 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 0.0 55 Expect. Value (H) 0.25 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 0811 10 02 10 February 2007/3
BILIRUBIN AUTO TOTAL FS Cat. No 1 0811.........
Notes 1. Please refer to the package insert for Bilirubin Auto
Total FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 0811 10 02 10 February 2007/3
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST TBIL # TEST NAME TBIL UNIT mg/dl
DATA MODE ON BOARD REPORT NAME Bilirubin Total
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
0.1 - 1.2 0.1 - 1.2
TECHNICAL LIMIT CLASS I CLASS 2
0 - 30.0 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 6 0 0 # (1)
(2) * # 6 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST TBIL
ASSAY CODE 2 point end 10 WAVELGH (SUB / MAIN)
660 / 546
ASSAY POINTS 15 - 31 - 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 6 0 0
S. VOL (DECREASE) 2 0 0
S.VOL (INCREASE) 12 0 0
ABS. LIMIT 0 2:INCREASE
PROZONE LIMIT 32000 1:HIGHER
REAGENT R1 240 0 269 #
R2 0 0 269 #
R3 60 0 269 #
R4 0 0 269 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 200
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name TBIL 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 546 11 Sample Volume 7 12 R1 VOLUME 280 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 32000 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 0.0 55 Expect. Value (H) 1.0 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 1802 10 02 10 August 2008/3
COMPLEMENT C3c FS Cat. No 1 1802.........
Notes 1. Please refer to the package insert for Complement
C3c FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 1812 10 02 10 August 2008/3
COMPLEMENT C4 FS Cat. No 1 1812.........
Notes 1. Please refer to the package insert for Complement
C4 FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 1130 10 02 10 September 2009/3
CALCIUM AS FS Cat. No 1 1130.........
Notes 1. Please refer to the package insert for Calcium AS
FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is 6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 1130 10 02 10 September 2009/3
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST CA # TEST NAME CA UNIT mg/dl
DATA MODE ON BOARD REPORT NAME Calcium
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
8.6 - 10.3 8.6 - 10.3
TECHNICAL LIMIT CLASS I CLASS 2
0 - 25.0 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 3 0 0 # (1)
(2) * # 3 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST CA
ASSAY CODE 1 point 10 WAVELGTH (SUB / MAIN)
700 / 660
ASSAY POINTS 31 - 0 - 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 3 0 0
S. VOL (DECREASE) 2 0 0
S.VOL (INCREASE) 6 0 0
ABS. LIMIT 0 2:INCREASE
PROZONE LIMIT 32000 1:HIGHER
REAGENT R1 250 0 381 #
R2 0 0 381 #
R3 0 0 381 #
R4 0 0 381 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 500
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name CAL 2 Assay Code (Mthd) 1 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 35 6 Assay Point 2 0 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 660 11 Sample Volume 3 12 R1 VOLUME 300 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 0 19 R3 Pos. 0 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 600 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 8.6 55 Expect. Value (H) 10.3 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 1121 10 02 10 September 2006/3
CALCIUM CPC FS Cat. No 1 1121.........
Notes 1. Please refer to the package insert for Calcium CPC
FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is 7 days provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 1121 10 02 10 September 2006/3
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST CA # TEST NAME CA UNIT mg/dl
DATA MODE ON BOARD REPORT NAME Calcium
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
8.6 - 10.3 8.6 - 10.3
TECHNICAL LIMIT CLASS I CLASS 2
0.2 - 20.0 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 5 0 0 # (1)
(2) * # 5 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST CA
ASSAY CODE 2 point 10 WAVELGTH (SUB / MAIN)
660 / 570
ASSAY POINTS 15 - 31 - 0- 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 5 0 0
S. VOL (DECREASE) 2 0 0
S.VOL (INCREASE) 10 0 0
ABS. LIMIT 0 2:INCREASE
PROZONE LIMIT 32000 1:HIGHER
REAGENT R1 240 0 380 #
R2 0 0 380 #
R3 60 0 380 #
R4 0 0 380 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 200
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name CA 2 Assay Code (Mthd) 2 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 570 11 Sample Volume 5 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 8.6 55 Expect. Value (H) 10.4 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 1181 10 02 10 March 2010/5
CALCIUM P FS Cat. No 1 1181.........
Notes 1. Please refer to the package insert for Calcium P FS
for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is 8 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 1181 10 02 10 March 2010/5
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST CA # TEST NAME CA UNIT mg/dl
DATA MODE ON BOARD REPORT NAME Calcium
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
8.6 - 10.3 8.6 - 10.3
TECHNICAL LIMIT CLASS I CLASS 2
0.1 - 25.0 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 3 0 0 # (1)
(2) * # 3 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST CA
ASSAY CODE 2 point end 10 WAVELGTH (SUB / MAIN)
800 / 660
ASSAY POINTS 15 - 31 - 0- 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 3 0 0
S. VOL (DECREASE) 3 0 0
S.VOL (INCREASE) 6 0 0
ABS. LIMIT 0 1:DECREASE
PROZONE LIMIT 32000 1:HIGHER
REAGENT R1 240 0 264 #
R2 0 0 264 #
R3 60 0 264 #
R4 0 0 264 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 500
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name CA 2 Assay Code (Mthd) 2 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 0 10 Wave Leng. (MAIN) 660 11 Sample Volume 3 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Decrease 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 8.6 55 Expect. Value (H) 10.4 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 1401 10 02 10 October 2008/5
CHOLINESTERASE FS Cat. No 1 1401.........
Notes 1. Please refer to the package insert for
Cholinesterase FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is 8 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 1401 10 02 10 October 2008/5
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST CHE # TEST NAME CHE UNIT U/l
DATA MODE ON BOARD REPORT NAME CHE
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
# - # # - #
TECHNICAL LIMIT CLASS I CLASS 2
0 - 20000 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0 # 4 0 0 # (1)
(2) * # 4 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST CHE
ASSAY CODE Rate A 10 WAVELGTH (SUB / MAIN)
/ 415
ASSAY POINTS 21 - 30- 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 4 0 0
S. VOL (DECREASE) 3 0 0
S.VOL (INCREASE) 5 0 0
ABS. LIMIT 0 1:DECREASE
PROZONE LIMIT 32000 1:HIGHER
REAGENT R1 200 0 434 #
R2 0 0 434 #
R3 50 0 434 #
R4 0 0 434 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 100
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ** The given factor must be checked by a calibratior ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name CHE 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 22 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 0 10 Wave Leng. (MAIN) 415 11 Sample Volume 4 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Decrease 51 Prz. Limit 32000 52 Prz. Limit (U/D) Higher 53 Prz. (End Point) 35 54 Expect. Value (L) # 55 Expect. Value (H) # 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 1200 10 02 10 September 2009/3
CHLORIDE FS Cat. No 1 1200.........
Notes 1. Please refer to the package insert for Chloride FS
for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is 7 days provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 1300 10 02 10 September 2005/2
CHOLESTEROL FS Cat. No 1 1300.........
Notes 1. Please refer to the package insert for Cholesterol
FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 1641 10 02 10 May 2010/2
CK-MB FS Cat. No 1 1641.........
Notes 1. Please refer to the package insert for CK-MB FS for
detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least 6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 1651 10 02 10 October 2009/6
CK-MB FS Cat. No 1 1651.........
Notes 1. Please refer to the package insert for CK-MB FS for
detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 1601 10 02 10 October 2009/6
CK-NAC FS Cat. No 1 1601.........
Notes 1. Please refer to the package insert for CK-NAC FS
for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 1601 10 02 10 October 2009/6
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST CK # TEST NAME CK UNIT U/L
DATA MODE ON BOARD REPORT NAME CK-NAC
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
# - # # - #
TECHNICAL LIMIT CLASS I CLASS 2
0 - 1100 -
STD CON POS S.VOL
.
PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 7 0 0 # (1)
(2) * # 7 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST CK
ASSAY CODE Rate A 10 WAVELGTH (SUB / MAIN)
415 / 340
ASSAY POINTS 22 - 30- 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 7 0 0
S. VOL (DECREASE) 3 0 0
S.VOL (INCREASE) 14 0 0
ABS. LIMIT 9000 2:INCREASE
PROZONE LIMIT 0 1:HIGHER
REAGENT R1 200 0 057 #
R2 0 0 057 #
R3 50 0 057 #
R4 0 0 057 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 200
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ** The given factor must be checked by a calibratior ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name CK 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 24 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 415 10 Wave Leng. (MAIN) 340 11 Sample Volume 7 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 9000 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 24 55 Expect. Value (H) 190 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 1711 10 02 10 March 2008/4
CREATININE FS Cat. No 1 1711.........
Notes 1. Please refer to the package insert for Creatinine FS
for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is 4 days provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 1711 10 02 10 March 2008/4
CREATININE FS Compensated Method To use the Creatinine FS Compensated Methodon the Hitachi 912, 911 and 902 the Instrument factor ’b’ must be changed as follows; When the units are mg/dL
Instrument Factor (Y=aX+b) b= - 0.3 When the units are µmol/L
Instrument Factor (Y=aX+b) b= - 27 To use the Creatinine Compensated Method on the Hitachi 717 go to Parameter Job, Chapter 7, Compensated Test and input the following formula; When the units are mg/dL [ (Crea test Code) ] [ - ] [ 0.3 ] [ ; ] When the units are µmol/L [ (Crea test Code) ] [ - ] [ 27 ] [ ; ] Note: Ensure that when using the Creatinine Compensated Method the relevant assigned Calibrator value is selected
#) Data entry by the user *) Calculated by the analyzer
845 1759 10 02 10 September 2005/2
CREATININE PAP FS Cat. No 1 1759.........
Notes 1. Please refer to the package insert for Creatinine
PAP FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 1759 10 02 10 September 2005/2
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST CREA # TEST NAME CREA UNIT mg/dl
DATA MODE ON BOARD REPORT NAME CREATININE
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
0.9 - 1.3 0.6 - 1.1
TECHNICAL LIMIT CLASS I CLASS 2
# - # -
STD CON POS S.VOL. PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 6 0 0 # (1)
(2) * # 6 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST CREA
ASSAY CODE 2 POINT END 10 WAVELGTH (SUB / MAIN)
700 / 546
ASSAY POINTS 15 - 31- 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 6 0 0
S. VOL (DECREASE) 2 0 0
S.VOL (INCREASE) 18 0 0
ABS. LIMIT 0 2:INCREASE
PROZONE LIMIT 0 LOWER
REAGENT R1 250 0 063 #
R2 0 0 063 #
R3 125 0 063 #
R4 0 0 063 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 1000
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name CRE 2 Assay Code (Mthd) 2 point end 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 546 11 Sample Volume 6 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 17 R2 Bottle Size Small 18 R3 VOLUME 125 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 1000 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 0.9 55 Expect. Value (H) 1.3 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 7045 10 42 10 August 2008/5
CRP U-hs High sensitive (hs) application
Cat. No 1 7045.........
Notes 1. Please refer to the package insert for CRP U-hs for
detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
8 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 7045 10 32 10 August 2008/5
CRP U-hs Universal (U) application Cat. No 1 7045.........
Notes 1. Please refer to the package insert for CRP U-hs for
detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
8 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 7002 10 02 10 August 2008/4
CRP FS Cat. No 1 7002.........
Notes 1. Please refer to the package insert for CRP FS for
detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 7059 10 02 10 August 2008/3
FERRITIN FS Cat. No 1 7059.........
Notes 1. Please refer to the package insert for Ferritin FS for
detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 2801 10 02 10 October 2009/3
GAMMA-GT FS (Szasz mod.) Cat. No 1 2801.........
Notes 1. Please refer to the package insert for Gamma-GT FS
(Szasz mod.) for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at
least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 2411 10 02 10 March 2009/1
GLDH FS DGKC Cat. No 1 2411.........
Notes 1. Please refer to the package insert for GLDH FS
DGKC for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 2500 10 02 10 February 2008/4
GLUCOSE GOD FS Cat. No 1 2500.........
Notes 1. Please refer to the package insert for Glucose GOD
FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 2511 10 02 10 March 2009/4
GLUCOSE HEXOKINASE FS Cat. No 1 2511.........
Notes 1. Please refer to the package insert for Glucose
Hexokinase FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 2511 10 02 10 March 2009/4
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST GLUC # TEST NAME GLUC UNIT mg/dl
DATA MODE ON BOARD REPORT NAME GLucose
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
70 - 115 70 - 115
TECHNICAL LIMIT CLASS I CLASS 2
2 - 500 -
STD CON POS S.VOL
.
PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 3 0 0 # (1)
(2) * # 3 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST GLUC
ASSAY CODE 2 point 10 WAVELGTH (SUB / MAIN)
376 / 340
ASSAY POINTS 15 - 31- 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 3 0 0
S. VOL (DECREASE) 1 0 0
S.VOL (INCREASE) 6 0 0
ABS. LIMIT 0 2:INCREASE
PROZONE LIMIT 0 LOWER
REAGENT R1 240 0 248 #
R2 0 0 248 #
R3 60 0 248 #
R4 0 0 248 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 100
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code ATTENTION This kit is for use with the original application. If you wish to use this included DiaSys application please contact your supplier for additional bar code labels.
#) Data entry by the user *) Calculated by the analyzer
845 3329 10 02 10 January 2010/7
HbA1c FS Cat. No 1 3329.....
Notes 1. Please refer to the package insert for oneHbA1c for
detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is 8
weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
Attention: Immediately after HbA1c measurement cleaning of cuvettes with NaOH-D solution is necessary. Please, refer to the information of the analyzer manufacturer. **This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 3521 10 02 10 September 2005/2
HDL-C IMMUNO FS Cat. No 1 3521.........
Notes 1. Please refer to the package insert for HDL-C
Immuno FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 3521 10 02 10 September 2005/2
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST HDL # TEST NAME HDL UNIT mg/dl
DATA MODE ON BOARD REPORT NAME HDL
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
35 - 80 35 - 80
TECHNICAL LIMIT CLASS I CLASS 2
1 - 180 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 3 0 0 # (1)
(2) * # 3 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST HDL
ASSAY CODE 2 point end 10 WAVELGH (SUB / MAIN)
700 / 600
ASSAY POINTS 15 - 31- 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 3 0 0
S. VOL (DECREASE) 3 0 0
S.VOL (INCREASE) 6 0 0
ABS. LIMIT 0 2:INCREASE
PROZONE LIMIT 0 LOWER
REAGENT R1 240 0 035 #
R2 0 0 035 #
R3 60 0 035 #
R4 0 0 035 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 100
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name HDL 2 Assay Code (Mthd) 2 point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 600 11 Sample Volume 3 12 R1 VOLUME 280 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 32000 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 0 54 Expect. Value (L) 35 55 Expect. Value (H) 85 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 7202 10 02 10 January 2009/4
IMMUNOGLOBULIN A FS Cat. No 1 7202.........
Notes 1. Please refer to the package insert for
Immunoglobulin A FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 7202 10 02 10 January 2009/4
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST IGA # TEST NAME IGA UNIT mg/dl
DATA MODE ON BOARD REPORT NAME IGA
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
# - # # - #
TECHNICAL LIMIT CLASS I CLASS 2
30 - 900 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 2 0 0 # (1)
(2) * # 2 0 0 # (2)
(3) * # 2 0 0 # (3)
(4) * # 2 0 0 # (4)
(5) * # 2 0 0 # (5)
(6) * # 2 0 0 # (6)
TEST IGA
ASSAY CODE 2 point end 10 WAVELGTH (SUB / MAIN)
0 / 570
ASSAY POINTS 15- 26 - 0- 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 2 0 0
S. VOL (DECREASE) 1 0 0
S.VOL (INCREASE) 4 0 0
ABS. LIMIT 0 2:INCREASE
PROZONE LIMIT 32000 1:HIGHER
REAGENT R1 250 0 777 #
R2 0 0 777 #
R3 50 0 777 #
R4 0 0 777 #
CALIB. TYPE [LOGIT/LOG] 6 6 1
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 999
SPAN 0 DUPLICATE LIMIT 1000
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name IgA 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 30 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) - 10 Wave Leng. (MAIN) 570 11 Sample Volume 3 12 R1 VOLUME 350 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Line-graph 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 1000 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) # 55 Expect. Value (H) # 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 7239 10 02 10 October 2009/3
IMMUNOGLOBULIN E FS Cat. No 1 7239.........
Notes 1. Please refer to the package insert for
Immunoglobulin E FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 7212 10 02 10 January 2009/4
IMMUNOGLOBULIN G FS Cat. No 1 7212.........
Notes 1. Please refer to the package insert for
Immunoglobulin G FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 7222 10 02 10 January 2009/4
IMMUNOGLOBULIN M FS Cat. No 1 7222.........
Notes 1. Please refer to the package insert for
Immunoglobulin M FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 1911 10 02 10 August 2008/4
IRON FS Ferene Cat. No 1 1911.........
Notes 1. Please refer to the package insert for Iron FS
Ferene for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 1911 10 02 10 August 2008/4
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST IRON # TEST NAME IRON UNIT µg/dl
DATA MODE ON BOARD REPORT NAME Iron
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
35 - 155 23 - 165
TECHNICAL LIMIT CLASS I CLASS 2
5 - 1000 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0 # 15 0 0 # (1)
(2) * # 15 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST IRON
ASSAY CODE 2 point end 10 WAVELGH (SUB / MAIN)
700 / 600
ASSAY POINTS 15 - 31- 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 15 0 0
S. VOL (DECREASE) 7 0 0
S.VOL (INCREASE) 20 0 0
ABS. LIMIT 0 2:INCREASE
PROZONE LIMIT 32000 1:HIGHER
REAGENT R1 240 0 661 #
R2 0 0 661 #
R3 60 0 661 #
R4 0 0 661 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 100
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name Iron 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 600 11 Sample Volume 15 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 23 55 Expect. Value (H) 168 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 4001 10 02 10 August 2008/4
LACTATE FS Cat. No 1 4001.........
Notes 1. Please refer to the package insert for Lactate FS for
detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
5 days provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 4001 10 02 10 August 2008/4
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST LAC # TEST NAME LAC UNIT mg/dl
DATA MODE ON BOARD REPORT NAME Lactate
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
# - # # - #
TECHNICAL LIMIT CLASS I CLASS 2
1 - 120 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0 # 4 0 0 # (1)
(2) * # 4 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST LAC
ASSAY CODE 2 point end 10 WAVELGTH (SUB / MAIN)
800 / 340
ASSAY POINTS 15 - 31- 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 4 0 0
S. VOL (DECREASE) 2 0 0
S.VOL (INCREASE) 8 0 0
ABS. LIMIT 32000 32000 1:INCREASE
PROZONE LIMIT 32000 32000 1:HIGHER
REAGENT R1 240 0 040 #
R2 0 0 040 #
R3 60 0 040 #
R4 0 0 040 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 200
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name LAC 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 800 10 Wave Leng. (MAIN) 340 11 Sample Volume 4 12 R1 VOLUME 280 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.00 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 200 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 32000 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 0.0 55 Expect. Value (H) 1.0 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 4201 10 02 10 October 2009/3
LDH FS DGKC Cat. No 1 4201.........
Notes 1. Please refer to the package insert for LDH DGKC
FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 4211 10 02 10 October 2009/5
LDH FS IFCC Cat. No 1 4211.........
Notes 1. Please refer to the package insert for LDH FS IFCC
for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is 10 days provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 4121 10 02 10 September 2005/2
LDL-C SELECT FS Cat. No 1 4121.........
Notes 1. Please refer to the package insert for LDL-C Select
FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 4121 10 02 10 September 2005/2
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST LDL # TEST NAME LDL UNIT mg/dl
DATA MODE ON BOARD REPORT NAME LDL Cholesterol
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
0 - 130 0 - 130
TECHNICAL LIMIT CLASS I CLASS 2
1 - 400 -
STD CO
N
PO
S
S.VO
L.
PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 3 0 0 # (1)
(2) * # 3 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST LDL
ASSAY CODE 2 point end 10 WAVELGH (SUB / MAIN)
700 / 600
ASSAY POINTS 15 - 31- 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 3 0 0
S. VOL (DECREASE) 1 0 0
S.VOL (INCREASE) 6 0 0
ABS. LIMIT 0 2:INCREASE
PROZONE LIMIT 0 LOWER
REAGENT R1 240 0 059 #
R2 0 0 059 #
R3 60 0 059 #
R4 0 0 059 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 100
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name LDL 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 600 11 Sample Volume 3 12 R1 VOLUME 280 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 32000 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 0 54 Expect. Value (L) 0 55 Expect. Value (H) 130 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 4321 10 02 10 August 2008/4
LIPASE DC FS Cat. No 1 4321.........
Notes 1. Please refer to the package insert for Lipase DC FS
for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 7139 10 02 10 September 2009/5
Lp(a) 21 FS Cat. No 1 7139.........
Notes 1. Please refer to the package insert for Lp (a) 21 FS
for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 4610 10 02 10 August 2008/4
MAGNESIUM XL FS Cat. No 1 4610.........
Notes 1. Please refer to the package insert for Magnesium
XL FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
3 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 5211 10 02 10 January 2009/5
PHOSPHATE FS Cat. No 1 5211.........
Notes 1. Please refer to the package insert for Phosphate FS
for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 5211 10 02 10 January 2009/5
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST PHOS # TEST NAME PHOS UNIT mg/dl
DATA MODE ON BOARD REPORT NAME Phosphate
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
2.6 - 4.5 1.8 - 2.6
TECHNICAL LIMIT CLASS I CLASS 2
0.2 - 40.0 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 3 0 0 # (1)
(2) * # 3 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST PHOS
ASSAY CODE 2 point end 10 WAVELGTH (SUB / MAIN)
660 / 340
ASSAY POINTS 15 - 31 - 0- 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 3 0 0
S. VOL (DECREASE) 2 0 0
S.VOL (INCREASE) 6 0 0
ABS. LIMIT 0 32000 2:INCREASE
PROZONE LIMIT 32000 0 1:HIGHER
REAGENT R1 240 0 394] #
R2 0 0 394] #
R3 60 0 394] #
R4 0 0 394] #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 200
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name PHOS 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 340 11 Sample Volume 3 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 200 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 1.8 55 Expect. Value (H) 4.5 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 7022 10 02 10 August 2008/6
RHEUMATOID FACTOR FS Cat. No 1 7022.........
Notes 1. Please refer to the package insert for Rheumatoid
Factor FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
3 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 2311 10 02 10 March 2009/4
TOTAL PROTEIN FS Cat. No 1 2311.........
Notes 1. Please refer to the package insert for Total Protein
FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is 10 days provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 0210 10 52 10 May 2009/4
TOTAL PROTEIN UC FS Cat. No 1 0210.........
Notes 1. Please refer to the package insert for Total Protein
UC FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 7252 10 02 10 September 2005/2
TRANSFERRIN FS Cat. No 1 7252.........
Notes 1. Please refer to the package insert for Transferrin FS
for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 5710 10 02 10 September 2005/2
TRIGLYCERIDES FS Cat. No 1 5710.........
Notes 1. Please refer to the package insert for Triglycerides
FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 1921 10 02 10 September 2009/4
UIBC FS Cat. No 1 1921.........
Notes 1. Please refer to the package insert for UIBC FS for
detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
6 days provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 1921 10 02 10 September 2009/4
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST UIBC # TEST NAME UIBC UNIT µg/dl
DATA MODE ON BOARD REPORT NAME UIBC
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
120 - 470 120 - 470
TECHNICAL LIMIT CLASS I CLASS 2
6 - 750 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0 # 18 0 0 # (1)
(2) * # 18 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST UIBC
ASSAY CODE 2 point end 10 WAVELGH (SUB / MAIN)
700 / 600
ASSAY POINTS 15 - 31- 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 18 0 0
S. VOL (DECREASE) 6 0 0
S.VOL (INCREASE) 20 0 0
ABS. LIMIT 0 2:INCREASE
PROZONE LIMIT 32000 1:HIGHER
REAGENT R1 240 0 785 #
R2 0 0 785 #
R3 60 0 785 #
R4 0 0 785 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 100
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name UIBC 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 600 11 Sample Volume 18 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 120 55 Expect. Value (H) 470 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 3101 10 02 10 September 2006/3
UREA FS Cat. No 1 3101.........
Notes 1. Please refer to the package insert for Urea FS for
detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is
6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) Data entry by the user *) Calculated by the analyzer
845 3021 10 02 10 March 2009/3
URIC ACID FS TBHBA Cat. No 1 3021.........
Notes 1. Please refer to the package insert for Uric Acid FS
TBHBA for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
#) data entry by the user *) enter calibration or standard value and position
845 3021 10 02 10 March 2009/3
BM / HITACHI 911
04-01 CHEMISTRY PARAMETERS
TEST UA # TEST NAME UA UNIT mg/dl
DATA MODE ON BOARD REPORT NAME Uric Acid
CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0
b 0.0
EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2
AGE M F
- -
- -
3.6 - 8.2 2.3 - 6.1
TECHNICAL LIMIT CLASS I CLASS 2
0.07 - 20.0 -
STD CON POS S.VOL PRE. DIL. VOL CODE
LOT
QUALITATIVE
NO
(1) 0.0 # 6 0 0 # (1)
(2) * # 6 0 0 # (2)
(3) (3)
(4) (4)
(5) (5)
(6) (6)
TEST UA
ASSAY CODE 2 point end 10 WAVELG
H
(SUB / MAIN)
700 / 546
ASSAY POINTS 15 - 31 - 0 - 0 DILUTION 301 99
< CLASS 1 > < CLASS 2 >
S.VOL (NORMAL) 6 0 0
S. VOL (DECREASE) 3 0 0
S.VOL (INCREASE) 10 0 0
ABS. LIMIT 0 2:INCREASE
PROZONE LIMIT 32000 1:HIGHER
REAGENT R1 240 0 398 #
R2 0 0 398 #
R3 60 0 398 #
R4 0 0 398 #
CALIB. TYPE [1:LINEAR] 2 2 0
AUTOCALIB.
TIME OUT BLANK 0 SD LIMIT 0.1
SPAN 0 DUPLICATE LIMIT 200
2 POINT 0 SENSITIVITY LIMIT 0
FULL 0 SI ABS. LIMIT -3200032000
CHANGE LOT NO COMPENSATED LIMIT
BOTTLE NO
# Data entry by the user * Enter calibration or standard value ## Enter the next code ## Enter the next code
BM / HITACHI 902
INSTRUMENT SETTINGS
No. <Chemistry> 1 Test Name UA 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 505 11 Sample Volume 4 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. 0 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 2.4 55 Expect. Value (H) 7.0 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #
#) Data entry by the user *) Calculated by the analyzer
845 3001 10 02 10 March 2009/4
URIC ACID FS TOOS Cat. No 1 3001.........
Notes 1. Please refer to the package insert for Uric Acid FS
TOOS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature
2. The stability of the reagent on board the analyser is 6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.